This proposed rule, if finalized, would amend existing color additive regulations by increasing fees for certification services. The fee schedule for color additive certification, as provided for in this proposed regulation, is designed to cover all the costs of operation of FDA’s color certification program. This includes both the cost of specific tests required by the regulations and the general costs associated with the certification program, such as the costs of accounting, reviewing data, issuing certificates, conducting research, inspecting establishments, and purchasing and maintaining equipment. The fee for certification services of straight colors including lakes would increase from $0.35 per pound to $0.45 per pound, with the minimum fee increasing from $224 to $288. The fees for repacks of certified color additives and color additive mixtures would increase from $35 for 100 pounds or less to $45. The fee for repacks of certified color additives and color additive mixtures over 100 pounds, but not over 1,000 pounds would increase from $35 plus $0.06 for each pound over 100 pounds to $45 plus $0.08 for each pound over 100 pounds. The fee for repacks of certified color additives and color additive mixtures over 1,000 pounds would increase from $89 plus $0.02 for each pound over 1,000 pounds to $114 plus $0.03 for each pound over 1,000 pounds.
The economic burdens of this proposed rule, if finalized, would accrue to color additive manufacturers. We estimate a one-time cost to read and understand the rule for all color additive manufacturers. The present value of this cost is approximately $2,307 at a 3 percent rate of discount, and $2,221 at a 7 percent rate of discount. The annualized value of these costs estimates is approximately $270 at a 3 percent discount rate and $316 at a 7 percent discount rate. Because the value of these impacts is small relative to manufacturer revenues, we assume that the supply of color additives would not be affected by this proposed rule. Consequently, we estimate no other impacts associated with this proposed rule. As the increase in fees is not associated with any change in the FDA certification program, no economic benefits are expected to result from the proposed rule. Similarly, the impact of the increase in certification fees on color additive manufacturers is considered a transfer, rather than an economic cost. Accordingly, we do not estimate economic benefits associated with this proposed rule, and the impact of the increase in color certification fees is estimated as an ongoing transfer from manufacturers of color additives to the federal government.
Regulatory Impact Analysis
Federal Register: 87 FR 66116, November 2, 2022